title: Efficacy and safety of once-daily esomeprazole for the treatment of gastroesophageal reflux disease in neonatal patients.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of proton pump inhibitors in infants aged <1 year with gastroesophageal reflux disease (GERD).
  
  
  METHODS
  In this randomized, double-blind, placebo-controlled multicenter study, neonates (premature to 1 month corrected age; n = 52) with signs and symptoms of GERD received esomeprazole 0.5 mg/kg or placebo once daily for up to 14 days. Change from baseline in the total number of GERD symptoms (from video monitoring) and GERD-related signs (from cardiorespiratory monitoring) was assessed with simultaneous esophageal pH, impedance, cardiorespiratory, and 8-hour video monitoring.
  
  
  RESULTS
  There were no significant differences between the esomeprazole and placebo groups in the percentage change from baseline in the total number of GERD-related signs and symptoms (-14.7% vs -14.1%, respectively). Mean change from baseline in total number of reflux episodes was not significantly different between esomeprazole and placebo (-7.43 vs -0.2, respectively); however, the percentage of time pH was <4.0 and the number of acidic reflux episodes >5 minutes in duration was significantly decreased with esomeprazole vs placebo (-10.7 vs 2.2 and -5.5 vs 1.0, respectively; P ≤ .0017). The number of patients with adverse events was similar between treatment groups.
  
  
  CONCLUSIONS
  Signs and symptoms of GERD traditionally attributed to acidic reflux in neonates were not significantly altered by esomeprazole treatment. Esomeprazole was well tolerated and reduced esophageal acid exposure and the number of acidic reflux events in neonates.
authors.affiliation: Women's and Children's Hospital, Children, Youth and Women's Health Service, North Adelaide, Australia.
authors.forename: Geoffrey
authors.initials: G
authors.lastname: Davidson
authors.forename: Tobias G
authors.initials: TG
authors.lastname: Wenzl
authors.forename: Michael
authors.initials: M
authors.lastname: Thomson
authors.forename: Taher
authors.initials: T
authors.lastname: Omari
authors.forename: Peter
authors.initials: P
authors.lastname: Barker
authors.forename: Per
authors.initials: P
authors.lastname: Lundborg
authors.forename: Marta
authors.initials: M
authors.lastname: Illueca
mesh_terms: D000284:Administration, Oral; D000704:Analysis of Variance; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D064098:Esomeprazole / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D005764:Gastroesophageal Reflux / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007234:Infant, Premature; D007235:Infant, Premature, Diseases / Q000175:diagnosis / Q000188:drug therapy; D057194:Intention to Treat Analysis; D008297:Male; D008991:Monitoring, Physiologic / Q000379:methods; D054328:Proton Pump Inhibitors / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D054328:Proton Pump Inhibitors; D064098:Esomeprazole
keywords: AE; Adverse event; GER; GERD; Gastroesophageal reflux; Gastroesophageal reflux disease; ITT; Intent-to-treat; LSM; Least square mean; PPI; Proton pump inhibitor; SAE; Serious adverse event